European Commission Works On Proposal To Delay MDR By One Year
At last there is news from the Commission that it is responding to the growing pressure to delay the implementation of the EU Medical Device Regulation. It looks like there will be a one-year reprieve. But uncertainty remains.
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For the first time, the EU medtech industry has called on the European institutions to postpone implementation of the Medical Device Regulation and the IVD Regulation until the COVID-19 crisis is over.
Two EU member states have waded into the argument about the likelihood of the system needed for the implementation of the new MDR being ready on time and believe “options for solutions” need to be considered.
While the UK is moving forward quickly to provide COVID-19 antibody self-testing, the Belgian government considers the tests not sufficiently accurate to be used in the pandemic.